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NeuroGlove PTSD Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06050590
Recruitment Status : Active, not recruiting
First Posted : September 22, 2023
Last Update Posted : September 22, 2023
Sponsor:
Information provided by (Responsible Party):
NeuroGlove LLC

Study Description
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Brief Summary:
This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

Condition or disease Intervention/treatment Phase
PTSD Post Traumatic Stress Disorder Device: NeuroGlove Not Applicable

Detailed Description:

This is a prospective, home-based, interventional clinical study in which 6 subjects will be enrolled. Six (6) subjects who suffer from post-traumatic stress disorder will receive treatment using the NeuroGlove.

There will be a single cohort in the study consisting of the subjects with PTSD who will receive treatment with NeuroGlove.

The trial is intended to evaluate the impact of the device use on active PTSD symptoms and subject sense of well-being.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: NeuroGlove
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Peripheral Sensory Stimulation of the Hand and Synchronized Deep Breathing in the Treatment of Post-Traumatic Stress Disorder: Assessing Safety and Effectiveness
Actual Study Start Date : August 14, 2023
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: NeuroGlove Treatment Arm
Study participants undergoing treatment using the NeuroGlove.
 Device: NeuroGlove
Study participant with PTSD will undergo daily at home treatment using the NeuroGlove.


Outcome Measures
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Primary Outcome Measures :
  1. PTSD Symptom Reduction [ Time Frame: 4 weeks ]
    Change in PTSD symptoms and subject's sense of well-being

  2. Portion of participants with adverse events [ Time Frame: 4 weeks ]
    Rate and severity of adverse events related to the use of the NeuroGlove.


Secondary Outcome Measures :
  1. PTSD Symptom Severity [ Time Frame: 4 weeks ]
    Change in severity of symptoms related to PTSD using NSESSS


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to and willing to provide informed consent. Legally authorized representatives (LARs) will not be allowed to consent on behalf of the subject.
  • Men and women ≥18 and <85 years of age.
  • Carry an active diagnosis of PTSD.
  • Suffer from PTSD symptoms that impact subject's daily activities and quality of life.

Exclusion Criteria:

  • Physical limitations of the upper extremity (e.g., fracture, joint deformity, severe spasticity/contracture, wounds, skin breakdown, lymphedema, etc.)
  • Subject lacks the ability to comprehend or following instructions, or for any reason, in the opinion of the investigator, would be unlikely or unable to comply with study protocol requirements.
  • Currently participating in another interventional clinical trial. (Observational clinical trial participation is allowed for study enrollment.)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050590


Locations
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United States, Minnesota
NeuroGlove
Saint Paul, Minnesota, United States, 55102
Sponsors and Collaborators
NeuroGlove LLC
Investigators
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Principal Investigator: Eric Nussbaum, MD NeuroGlove LLC
More Information
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Responsible Party: NeuroGlove LLC
ClinicalTrials.gov Identifier: NCT06050590    
Other Study ID Numbers: REG-1003
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: September 22, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will only be used by the sponsor organization and investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NeuroGlove LLC:
PTSD
Post Traumatic Stress Disorder
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders